Results of a Prospective Randomized Multicenter Study Comparing Indocyanine Green (ICG) Fluorescence Combined with a Standard Tracer Versus ICG Alone for Sentinel Lymph Node Biopsy in Early Breast Cancer: The INFLUENCE Trial

Abstract

Abstract Background For clinically node-negative early breast cancer patients, sentinel lymph node biopsy (SLNB) using dual localization with blue dye and radioisotope (RI) is currently standard of care. Documented disadvantages with these tracers have prompted exploration of alternative agents such as fluorescent indocyanine green (ICG), which demonstrates high detection rates combined with other tracers. Results of a randomized study evaluating ICG as a single tracer for SLN identification are presented. Methods Overall, 100 patients with unilateral, clinically node-negative, biopsy-proven invasive breast cancer (≤5 cm) scheduled for SLNB were recruited in two separate randomized cohorts, with 50 patients receiving ICG alone. Cohort 1 received ICG alone (n = 25) or combined with RI [Technetium99] (n = 25), while Cohort 2 received ICG alone (n = 25) or combined with blue dye (n = 25). The primary outcome was sensitivity for SLN identification. Results Among evaluable patients (n = 97), the overall SLN identification rate was 96.9% (ICG alone = 97.9%; ICG + RI = 100%; ICG + blue dye = 92%). Node positivity rates were 14.9% for ICG alone, 16% for ICG combined with RI, and 20% for ICG combined with blue dye. There were no significant differences (p < 0.05) in performance parameters, with ICG alone being non-inferior to tracer combinations for procedural node positivity rates when adjusted for specific factors. Conclusion These results support potential use of ICG as a sole tracer agent for routine SLNB, thereby avoiding disadvantages of RI and/or blue dye. The latter can be safely withheld as a co-tracer without compromising detection of positive nodes in primary surgical patients.